Class II · Moderate risk
Midazolam HCl 100 mg/100 mL in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Midazolam HCl 50 mg/50 mL in 0.9% Sodium Chloride
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
Midazolam HCl 50 mg/50 mL in 0.9% Sodium Chloride (1 mg/mL), Single-Dose Syringe, Hospital/Office Use Only, Rx Only, Cantrell Drug Co. 7321 Cantrell Road Little Rock, AR 72207, NDC 52533-001-04
Affected NDC
52533-0001-04
Compare with the code on your package — it is the most precise check available.
Drug: Midazolam
- Recalling firm
- Cantrell Drug Company
- NDC code
- 52533-001-04
- Origin
- AR, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0198-2017 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Midazolam recalls
See all
Class I · High risk
Midazolam in 0.8% Sodium Chloride Injection 100 mg/100 mL
Presence of Particulate Matter: Silicone
Class II · Moderate risk
midazolam in dextrose 5%
Lack of assurance of sterility:
Class II · Moderate risk
midazolam in dextrose 5%
Lack of assurance of sterility: Lack of validation data for sanitization cycles
Class II · Moderate risk
Midazolam Injection
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Other recalls by Cantrell Drug Company
All 2016 recalls
Class II · Moderate risk
Rocuronium Bromide Injection Solution 5 mL
Lack of Sterility Assurance.
Class II · Moderate risk
Neostigmine Methylsulfate Injection Solution 5 mL
Lack of Sterility Assurance.
Class II · Moderate risk
Adenosine in 0.9% Sodium Chloride 30mL
Lack of Sterility Assurance.
Class II · Moderate risk
Sodium Bicarbonate 8.4% Injection Solution 50 mL
Lack of Sterility Assurance.
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